Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, October 31, 2014

Sometimes an apparently insignificant noise can signal a big problem, like the sound of dripping water in a room with no visible plumbing.

Today, I noticed a few short stories in the media about one relatively small legal settlement involving a medical device company. It initially seemed to be too insignificant a settlement to merit a comment. A closer look, however, suggested links to to other larger issues. This story reminded me about other apparently small cases that are mostly ignored, but remind us of bigger problems.

Biomet Inc. has agreed to pay more than $6 million to resolve
allegations that it paid kickbacks to encourage doctors to use its bone
growth stimulators, the U.S. Justice Department announced Wednesday.

The
Warsaw-based orthopedic devices company signed the agreement along with
its subsidiary, EBI LLC, which is doing business as Biomet Spine and
Bone Healing Technologies. EBI, based in Parsippany, New Jersey, sells
bone growth stimulators, which are used to repair slow-healing fractures
without surgery.

Federal official allege that from 2001 to 2008,
EBI bribed staffers in physicians' offices to persuade them to use the
products.

The story also included the usual tough quotes from law enforcement, including this from US Attorney for the Massachusetts district Carmen Ortiz,

This settlement demonstrates our resolve in ensuring that patients
receive, and the government pays for, health care that is based on sound
medical judgment, not compromised by kickbacks....

That was it. A mere $6 million was the charge to settle allegations that the device company gave kickbacks to physicians' office staff to induce the doctors to use the company's product. As is usually the case, no individuals who authorized, directed or implemented the questionable activities were named, much less suffered any consequences.

- Starting in 2007, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints, Biomet, DePuy Orthopaedics,a unit of Johnson & Johnson, Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew,
revealed they made to orthopedic surgeons and various academic and
other organizations in the US. All companies except Stryker were charged
with "criminal conspiracy to violate anti-kickback laws," and all were
subject to deferred prosecution agreements.
- In 2012, we posted about how Biomet paid nearly $23 million, including a $17.3 million criminal fine, which appears to imply a guilty plea, to charges that it gave kickbacks to foreign physicians, thus violating the US Foreign Corrupt Practices Act

So this tiny case, that is, in a monetary sense, suggests that Biomet is another recidivist corporation, and that the deferred prosecution agreement it signed in 2007 was useless, since it did not deter activities that occurred in 2008 and perhaps later.

Furthermore, haven't we heard of Carmen Ortiz before? In 2013, we posted that Ms Ortiz was involved in settling three big cases, involving allegations that Forest Pharmaceuticals promoted Celexa in adolescents despite the drug's likely dangers to them, GlaxoSmithKline used misleading drug packaging, also likely endangering patients, and St Jude Medical gave kickbacks to doctors to induce them to implant medical devices. All cases were settled with fines, but again no individuals suffered any negative consequences. However, in contrast, Ms Ortiz was also the prosecutor who proved how tough she was when she threatened activist Aaron Swartz with serious prison time for alleged computer fraud, driving Mr Swartz to suicide.

Biomet and Zimmer

Finally, Biomet is slated to merge with Zimmer Holdings Inc, another large medical device company. Zimmer was also involved in the 2007 prosthetic hips and knees settlement, charged with criminal conspiracy to violate kickback laws, and subject to a deferred prosecution agreement (see summary in this post). So the combined company, whose formation is now subject to a European Union inquiry due to concerns about potentially anti-competitive aspects (see the Wall Street Journal article), would end up with quite a concerning track record.

So this little case reminds us that when a big health care organization is accused of kickbacks or similar unethical activities that may endanger patients, even supposedly tough law enforcers almost never try to hold any individuals accountable, and that absent such accountability, such organizations often become serial legal settlers, accused again and again of unethical or criminal acts that are bad for patients and the public health.

Yet again, nobody seemed to notice this case.

Little Cases that Add Up

While this case was small, it had some links to bigger past issues. It reminded me that I have seen lots of other small cases, which often seemed to small to discuss at the time they occurred.

Thus, it also inspired me to finally pull from my dusty files a host of media reports of little cases which I put away because they seemed to small to individually merit comment at the times they appeared. I quickly summarize some of them below. To make the list manageable, I limited it to cases since 2012 involving medical device companies. In alphabetical order....

Arthrocare Executives Guilty of Securities Fraud (2014)

This case was unusual since it actually involved serious jail time for individual, but perhaps that was because this was a financial crime that did not endanger patients (see the Bloomberg article). The prosecutor called it an "epic tale of greed" after the CEO and CFO were convicted. In 2013, two Vice Presidents, including the head of Strategic Business Units, had also pleaded guilty (see this Bloomberg article).

This was standard issue, including a fine of $6 million, allegations of kickbacks, some in the form of speakers' or consulting fees to surgeons for use of the company's back surgery devices, but not admissions of wrongdoing and no penalties for individuals, per the AP.

This was another standard issue settlement involving a fine of $5.25 million, allegations of kickbacks to physicians to encourage them to use the company's devices, and a corporate integrity agreement, but no admissions of wrongdoing and no penalties for individuals, per the AP via the Billings (Montana) Gazette.

The only media outlet to report this small case was Reuters. The company, which was then privately held, and its CEO combined paid $1 million to settle US Food and Drug Administration charges it sold unapproved devices. Now the company is apparently public, and its most recent proxy statement disclosed its CEO is currently in the million dollar plus club.

Home Diagnostics Inc Ex-CEO Pleaded Guilty to Insider Trading (2012)

He pleaded guilty to SEC charges that he tipped two people about the company's impending buyout by Nipro Corp, per Bloomberg. His sentence was three years of probation and a fine of $260,000, again per Bloomberg.

As reported by the Portland (Oregon) Business Journal, the Johnson and Johnson subsidiary settled state claims for $4 million that it marketed its ASR XL metal on metal hip joint without disclosing its known high rate of failure. The company did not admit wrongdoing, and no individual paid a penalty. Note that Bloomberg reported, "While the sum is dwarfed by J&J’s earlier settlement of
patient lawsuits linked to the ASR hip, the agreement may lead
the way for additional accords as federal and multi-state probes
continue into the company’s sales of the device." So it is quite possible there will be more and/or bigger settlements involving the marketing of this device. Johnson and Johnson has quite an extensive record of mischief (look here). Johnson and Johnson's DePuy subsidiary, along with Biomet and Zimmer, settled charges of criminal conspiracies to violate anti-kickback laws in the hips and knees settlements of 2007.

Summary

Note that the summary of little cases suggested that the bigger the company, the less likely is any individual to be held responsible. Those cases that included individual penalties were all of relatively small companies. One of those was privately held at the time the case was made public. One individual who paid a penalty was the leader of a previously small company who held that position prior to the buyout of his company by a larger one. Furthermore, note that insider trading seems to be treated more severely than actions that violate professional ethics, like kickbacks to doctors, or might harm patients. The only individuals who went to prison or put on probation were company leaders who committed securities fraud or insider trading. No one involved in giving kickbacks to physicians, deceptive marketing, etc paid any penalties.

The impunity of managers of big companies, especially in cases in which the charges involved actions that likely endangered patients and violated health care professionals values, is underlined by our look at "little cases." Yet this impunity remains unexplained, and has certainly not been addressed by law enforcement authorities.

So the Kabuki play that is regulation of and law enforcement for large
health care organizations goes on. As our society is being increasingly
divided into a huge majority in increasingly difficult economic
circumstances and a small and increasingly rich minority, it also seems
to be increasingly divided into little people who may be ruined by
lawsuits, and imprisoned for even minor infractions, and big people who
have impunity.

True health care reform would hold leaders of health care organizations
accountable for their organizations' behavior, and its effects on
patients and health care professionals.

Digitizing medical records was supposed to transform health care—improving the quality of care and the service provided to patients while helping cut out unnecessary costs. Just like IT revolutionized all other industries.

Perhaps they still will. But lately, electronic medical record systems are getting nothing but votes of no-confidence from physicians, hospitals, insurers and IT experts.

Dr. Clem McDonald, who did more than anyone to advance electronic medical records during his 35 years at the Indianapolis-based Regenstrief Institute, called the 5-year, $27 billion push to roll out electronic medical records “disappointing” and even a “tragedy” last month during a talk with health care reporters (including me) at the National Institutes of Health in Bethesda, Maryland.

I agree with those sentiments. The botched industry approach to clinical information technology has set back the cause of good health IT severely, largely through clinician disenfranchisement. That dissatisfaction and disappointment will not be easy to reverse - and never should have needed to have been reversed.

... “It’s sort of a tragedy because everybody’s well-intentioned,” said
McDonald, who spearheaded one of the nation’s first electronic medical
record systems at Regenstrief and what is now Eskenazi Health.
McDonald’s work in Indianapolis on the electronic exchange of medical
records put patients here at least a decade ahead of those in most of
the country in benefiting from the technology.

I'm not so sure that perverse behaviors such as willful blindness to the risks, profiteering, and indifference to harms caused by these systems, as I've documented at this blog and elsewhere count as "well-intentioned" (e.g., "FDA on health IT
risk: "We don't know
the magnitude of the risk, and what we do know is the tip of the
iceberg, but health IT is of 'sufficiently low risk' that we don't need
to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

... McDonald now has a nationally influential post to promote electronic
medical records, as the director of the Lister Hill Center for
Biomedical Communications, a part of the National Library of Medicine,
which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

That may be true regarding data entry time. I'd say the amount is likely more when accounting for confusion and communications difficulties that bad health IT causes.

... One-third of physicians surveyed said it took longer to find and review
medical record data. One-third also said it was slower to read other
clinicians’ notes.

“Some docs don’t even read reports any more. This is a perverse side
effect,” McDonald said, noting that the electronic reports have so much
information in them, that they become “endless and mindless.”

I have used the term "perverse" in the past regarding commercial health IT; this is the first time I recall seeing the term from one of the EHR pioneers.

... More bad news about electronic health records came out this week in a new research study.
It found that physicians using electronic medical records spend an
extra 16 minutes per day, on average, doing administrative tasks than
their peers who still use only paper.

The study relied on data from 2008—which when compared with McDonald’s
study suggests EMRs are now consuming more of doctors’ time than they
were before the federal push to expand their use.

“Although proponents of electronic medical records have long promised a
reduction in doctors’ paperwork, we found the reverse is true,” wrote
study authors Steffie Woolhandler and David Himmelstein.

Yet we still hear promises about "increased efficiency" and reduction of clinicians' administrative tasks and paperwork due to health IT. When will that canard be put to rest, one might wonder?

In my view, the experiment of making clinicians perform EHR clerical work has been a failure.

And it was, in fact, an experiment in the full sense of the word. It was done with little clue as to the true effects on patient care.

From the article:

... So with so many so upset with electronic health records, why is McDonald still optimistic?

He thinks the problems folks are having aren’t inherent to the
technology itself, but are instead caused by overly restrictive rules
coming both from the federal government and from hospital systems.

Hospital systems, knowing that more information can be recorded now that it’s electronic, have insisted that doctors do more documenting. McDonald cited one research study that found that documentation requirements have doubled in the past decade.

“I think they’ve got to ask less,” McDonald said of hospital administrators. “Nobody has any idea of the time-cost of one more data entry.”

I don't share that optimism or a belief physicians will be asked to "do less" with EHRs, since physicians have essentially abrogated their professional independence and autonomy, and are increasingly becoming servants of their business-degree masters - and of bad technology.

DaVita Healthcare Partners, Inc., one of the leading providers of
dialysis services in the United States, has agreed to pay $350 million
to resolve claims that it violated the False Claims Act by paying
kickbacks to induce the referral of patients to its dialysis clinics,...

This amount was augmented by

a Civil Forfeiture in the amount of $39 million based upon conduct
related to two specific joint venture transactions entered into in
Denver, Colorado.

DaVita, by the way, has agreed in principle to pay another $11 million
to several states that filed false claims charges, according to a document that DaVita filed with the U.S. Securities and Exchange Commission. The DaVita spokesman says the deal involves five states.

So the total cost to the company seems to be about $400 million. The settlement also included a corporate integrity agreement,

DaVita has entered into a Corporate Integrity Agreement with the Office
of Counsel to the Inspector General of the Department of Health and
Human Services which requires it to unwind some of its business
arrangements and restructure others, and includes the appointment of an
Independent Monitor to prospectively review DaVita’s arrangements with
nephrologists and other health care providers for compliance with the
Anti-Kickback Statute.

Kickbacks to Doctors who Refer Dialysis Patients

Here is how the kickbacks worked.

First, using information gathered from numerous sources, DaVita
identified physicians or physician groups that had significant patient
populations suffering renal disease within a specific geographic area.
DaVita would then gather specific information about the physicians or
physician group to determine if they would be a 'winning practice.' In
one transaction, a physician’s group was considered a “winning practice”
because the physicians were 'young and in debt.' Based on this careful
vetting process, DaVita knew and expected that many, if not most, of
the physicians’ patients would be referred to the joint venture dialysis
clinics.

Next, DaVita would offer the targeted physician or physician group a
lucrative opportunity to enter into a joint venture involving DaVita’s
acquisition of an interest in dialysis clinics owned by the physicians,
and/or DaVita’s sale of an interest in its dialysis clinics to the
physicians. To make the transaction financially attractive to potential
physician partners, DaVita would manipulate the financial models used to
value the transaction.

So these alleged kickbacks were not envelopes full of unmarked bills, but sophisticated, complex transactions that would be hard for outsiders to understand.

To ensure that those bought stayed bought,

Last, DaVita ensured future patient referrals through a series of
secondary agreements with their physician partners. These included
paying the physicians to serve as medical directors of the joint venture
clinics, and entering into agreements in which the physicians agreed
not to compete with the clinic. The non-compete agreements were
structured so that they bound all physicians in a practice group, even
if some of the physicians were not part of the joint venture
arrangements. These agreements also included provisions prohibiting the
physician partners from inducing or advising a patient to seek treatment
at a competing dialysis clinic. These agreements were of such
importance to DaVita that it would not conclude a joint venture
transaction without them.

Note that these alleged arrangements ensured the private gains of the physicians involved, and presumably by increasing referrals, ensured the private gains of DaVita, and likely specific managers whose remuneration depended on the fees produced by referrals. However, the arrangements steered patients to dialysis services not based on what would be best for patients but what would be best for those involved in the arrangements. Thus these arrangements appeared to fit the Transparency International definition of corruption: "abuse of entrusted power for private gain." The physicians were entrusted to provide the best possible care of individual patients, yet they put their and the company (and likely the company's managers) financial gain ahead of the patients' care.

No One Admitted Anything or Suffered Any Negative Consequences

Although the company paid a fine and entered into the corporate integrity agreement, apparently no individuals, be they physicians or company managers, paid any sort of penalty.

Like many other settlements we discussed, the company paid out a lot of money but denied it did so because it did anything wrong. Ed Silverman wrote on the PharmaLot blog

In a statement,
DaVita says it is 'pleased to announce a civil resolution' and that 'patient care was never an issue, nor were billing or payment practices…
We are proud of our commitment to compliance over our 15-year history.'

'We have worked incredibly hard to get things right and it is our
belief there was no intentional wrongdoing. We believe this settlement
is the right thing to do for our teammates, partners and shareholders.
It allows us to move forward with heightened clarity and transparency,
both with regulators and our physician partners.'

Why it was good for shareholders and "teammates and partners," presumably meaning employees to pay so much money in the absence of "intentional wrongdoing," when the money would likely come out of stock value and employees' salaries, was not explained. Why patient care was "not an issue" when the allegations were that patients were steered to dialysis providers because of financial inducements given to doctors, not due to any consideration of patients' needs and welfare also was not explained.

In a July 2009 e-mail cited in the whistleblower lawsuit, which was
also filed in federal court in Colorado, one DaVita executive asks for
suggestions on how to ensure the financial models used to value
transactions pass internal standards. Another executive replies 'You
mean gaming the model, right?' To which the first exec writes, 'I do.'

'I think there was a pretty wide understanding that what was going on
was questionable at best,' David Barbetta, the former DaVita senior
financial analyst, tells us. He says he worked at DaVita from March 2007
until August 2009, when he resigned after being disturbed by several
joint venture transactions.

Barbetta, who is now an independent technology consultant, says he
mentioned concerns to DaVita managers, but was ignored. 'I did raise
this with someone who was a vice president, but he just said not give
him any of that ethics nonsense,' he tells us. 'He was a vp and I was an
analyst, so I pretty much looked at him and didn’t really push the
issue any further.'

One vice president warned Barbetta not to 'give me any of that ethics crap,' court documents state.

And, in internal
company e-mails Barbetta provided to the government, top DaVita
officials boasted of 'gaming' valuation models. Barbetta also told
prosecutors that another DaVita manager once explained to him the
deals were used to funnel 'a bag of money' to physicians. Those doctors,
in exchange, steered dialysis patients to DaVita.

Why there was no further investigation of these executives, and those to whom they reported, was also not explained.

Just the Latest Settlement

The few media reports of this settlement suggested that this was not DaVita's first settlement.

The 2000 and 2004 Gambro Inc Settlements

The current DOJ release noted that DaVita

had previously been in a joint venture arrangement involving dialysis
clinics with Gambro, Inc., a dialysis company acquired by DaVita in
2005. Prior to the acquisition, Gambro had entered into a settlement
with the United States to resolve alleged kickback allegations that,
among other things, required Gambro to unwind its joint venture
agreements.

In
2000, Gambro Healthcare and its subsidiary, Gambro Healthcare Laboratory
Services, agreed to pay $40 million to settle allegations of healthcare fraud.
Gambro and another subsidiary, Dialysis Holdings Laboratory Services, Inc.
(DHLSI), have agreed to pay more than $13.1 million to settle similar
allegations.

However, in 2004, a much bigger Gambro settlement was announced,

Gambro Healthcare will pay more than $350 million in
criminal fines and civil penalties to settle allegations of healthcare fraud
in the Medicare, Medicaid and TRICARE programs,...

Aspects of this settlement were eerily similar to those of the latest DaVita settlement,

As part of this comprehensive global
resolution, Gambro Supply Corporation, a sham durable medical equipment
company and a wholly owned subsidiary of Gambro Healthcare, admitted to the
execution of a healthcare fraud scheme and agreed to plead guilty to criminal
felony charges, pay a $25 million fine and be permanently excluded from the
Medicare program.

Gambro Healthcare will also pay in excess of $310 million to resolve civil
liabilities stemming from alleged kickbacks paid to physicians, false
statements made to procure payment for unnecessary tests and services, and
payments made to Gambro Supply. The settlement also requires Gambro to
allocate an additional $15 million to resolve potential liability for the
conduct resolved under the federal agreement pursuant to a preliminary
understanding reached with representatives of various state Medicaid programs.
Gambro Healthcare has also entered into a comprehensive Corporate Integrity
Agreement.

Note that this older settlement actually involved admissions of wrongdoing, fraud, and a guilty plea by a subsidiary to federal felonies. .

DaVita's proposed acquisition of the criminal Gambro also provoked allegations by the US Federal Trade Commission of illegal anti competitive activities. In a 2005 FTC news release,

According to the Commission’s complaint, DaVita’s proposed acquisition
of Gambro would be anticompetitive and in violation of Section 5 of the
FTC Act and Section 7 of the Clayton Act, as amended. DaVita and Gambro
account for a significant proportion of the dialysis clinics and
treatment stations in many local areas in the United States, and the
acquisition, if consummated, would lessen competition for outpatient
dialysis services in 35 markets nationwide.

Kidney dialysis
giant DaVita Inc. has settled a whistleblower lawsuit for the first
time, agreeing to pay $55 million over allegations of drug overuse
while denying any wrongdoing.

Denver-based DaVita settled fraud
claims in a Texas lawsuit challenging the dialysis chain's past use of
Epogen, an anemia drug whose high cost and dangers helped change how the
government pays for kidney care.

Note that this case suggested actions that could have hurt patients,

The Texas whistleblower lawsuit accused DaVita of using more Epogen than was medically necessary,...

Epogen is not without serious adverse effects, as noted above, and overdosing multiple patients with it made it likely that some were harmed.

Further, while

DaVita said it was
the first time it was settling a claim over federal anti-fraud laws, but
noted the government had declined to join the whistleblower' s lawsuit.

Only two years later DaVita had to settle more federal claims, this time due to a suit that the federal government had certainly joined. And as noted above, a company which DaVita was about to acquire as a subsidiary had admitted to fraud and pleaded guilty to federal charges apparently involving fraud just before the acquisition.

Finally, just as in 2014, in 2012 DaVita denied responsibility,

'DaVita and its
affiliated physicians did nothing wrong and stand by their anemia
management practices, which were always consistent with their mission of
providing the best possible care for each patient,' a company statement
said.

Summary

The latest settlement by DaVita was of allegations that the company gave kickbacks to physicians to get them to refer patients to DaVita facilities, regardless of the patients' best interests. The company paid about $400 million and signed a corporate integrity agreement, but no individual who authorized, directed, or implemented the provision of kickbacks was identified, or paid any penalties. This settlement turns out to have been only the latest settlement by DaVita or companies it acquired. Previous settlements involved penalties of $53 million, $350 million, and $55 million (totaling more than three-quarters of a billion dollars from 2004 to 2014. Previous settlements were for kickbacks and fraud. One included a guilty plea to a felony. Previous settlements involved alleged and sometimes admitted behavior that likely put patients at risk. One earlier settlement also included a corporate integrity agreement. However, no settlement imposed any negative consequences on any individual who authorized, directed, or implemented the bad, and sometimes criminal behavior.

Integrity
We say what we believe, and we do what we say. We are trusted because
we are trustworthy. In our personal, team, and organizational values,
we strive for alignment in what we say and do.

and

Accountability
We don’t say, 'It’s not my fault,' or 'It’s not my job.' We take
responsibility for meeting our commitments — our personal ones as well
as those of the entire organization. We take ownership of the results.

Despite the fact that the above settlements made a mockery of these lofty values, the company managers who presided over the behavior that lead to them prospered mightily during this time period. The company' 2014 proxy statement showed the current CEO and board chairman Kent J Thiry received $17,099,257 in total compensation in 2013. The five next best paid executives received collectively about $22 million. Note that Mr Thiry as been CEO since 1999, and thus all the above settlements and most of the behavior that led to them occurred on his watch.

So the march of legal settlements continues in step with the same old song. Big health care organizations preach their lofty missions and values, pay their top managers millions, and in some cases turn them into billionaires, while the organizations are accruing amazing records of bad and sometimes criminal corporate behavior. The legal settlements only provide hints as to this behavior, but nearly every time, the management need not admit nor deny wrongdoing while merrily going on to collect their next huge paycheck which was justified by the corporate financial performance in part generated by the bad behavior.

Leadership that cares not for honesty, transparency, or accountability, and that puts short term revenue, and usually personal enrichment ahead of patients' and the public's health may be the single most important reason that US health care is so dysfunctional. Yet hardly anyone even dares discuss the damning facts about health care leadership, much less propose solutions. If we do not reform our health care leadership so that it is transparent, honest, accountable, unconflicted, and it puts patients' and the public's health over personal enrichment, our health care system will continue to founder.

At "Congressional committee releases timeline detailing how Presbyterian treated Ebola patient Thomas Eric Duncan", Dallas News, Oct. 17, 2014 there is a link that provides acccess to documents released by the U.S. House of Representatives' Energy and Commerce Committee.

According to a timeline released moments ago by the U.S. House Energy and Commerce Committee, Texas Health Resources Presbyterian Hospital Dallas released Thomas Eric Duncan at 3:37 a.m. on Sept. 26 — just 35 minutes after his temperate jumped to 103 degrees.

The timeline, provided by Presbyterian officials, also shows that “obtaining the patient’s travel history was not part of the triage nurses’ process on September 25, 2014,” when Duncan initially went to the hospital. He arrived in Dallas from Liberia five days earlier. A nurse noted that he’d just come from Africa but “attached no further significance to this travel history,” according to the timeline.

Another document shows how Presbyterian prepared to deal with Ebola dating back to Aug. 1 when officials were told that all Emergency Health Records should include a travel history for every patient. In Duncan’s case, it’s not clear whether a doctor read his emergency health records.

“The record does not show which information the physician read, only which information was available,” according to the timeline.

The key phrase to parse is the one also quoted in the newspaper article above: “The record does not show which information the physician read, only which information was available.”

From the timeline itself, in pertinent part:

12:33 – 12:44 a.m. RN assessment
- The primary ED nurse continues the assessment.
- She identifies his complaints as “sharp, intermittent epigastric/upper abdominal pain;
sharp, frontal headache; dizziness; lack of appetite”- She asks about Mr. Duncan’s travel history.- The nurse documents that Mr. Duncan “came from Africa 9/20/14"- RN states she recalls the discussion because of how long the plane flight was. (She had personal experience with very long plane fights). Attached no further significance to this travel history.
- This information was not verbally communicated to the physician, as prompted by the EHR.

12:52 – 1:10 a.m. ED physician begins evaluation of Mr. Duncan
The ED physician accesses the EHR again. A review of the EHR shows that the physician, on several occasions, accessed portions of the EHR where the travel history was now available including:
ED Lab Results Screen
ED Triage [twice]
ED Rad Results

The record does not show which information the physician read, only which information was available.

Again, the statements that the physicians "accessed portions of the EHR where the travel history was now available" after the RN recorded it, and that "the record does not show which information the physician read, only which information was available" sound like lawyers writing to obfuscate EHR realities from our Congresspeople.

Let's examine these statements:

ED physicians "accessed portionsof the EHR where the travel history was now available" after the RN recorded it, and

The record does not show which information the physician read, only which information was available

These is a fundamental semantic problem here with the word "available." In an EHR, "available" has a far different meaning than in a paper record.

The question is:

What is the precise meaning of the word "available" as stated here?

(1) Does "available" mean "present on the actual screen(s) the physicians had up at one time or another on the monitor, that made up the "portions" of the EHR they "accessed"?"

In other words, was the positive travel history from Africa "illuminating the phosphor", or illuminating the LED arrays for a modern computer monitor, of an actual screen in actual eyesight of the physicians that was a subset of the "portions of the EHR" they accessed?

Or (and I believe this quite possible):

(2) Does "available" mean that the travel history was available as data on disk or on RAM, and thus potentially on a screen for a physician to see, but that the specific screen never actually illuminated the LED arrays on the physicians' monitors? (E.g., such screen(s) were a component or subcomponent of the EHR "portions" they accessed, but the specific screen(s) in those "portions" had to be navigated to in order to see the travel data.)

In other words, was the case that the travel information taken by the nurse never appeared visually to the physicians, but only resided in the computer as data where it was invisible as intangible bytes on a disk or in RAM? (This does not happen with a paper chart - the paper is tangible.)

Further, was there a meaningful alert drawing the physician to a screen that did then present the travel data to them?

There is no way to know by parsing the words, but based on their semantic blur I suspect the second scenario.

Unfortunately, what really is essential to understand the EHR interaction are screenshots of precisely the screens viewed by the physicians, not "available" to the physicians.

Note that, for example, my Windows System Event log is "available" to me at all times in "portions" of Windows I may look at - by right-clicking "My Computer" and clicking the "manage" menu item that appears - and only then if I actually then navigate to find it.

Of course, EPIC and the other EHR sellers do not make the actual EHR screens available to the public - they are considered "protected IP."

Perhaps it's time for EPIC and the Texas Health Presbyterian Hospital to show Congress their screens.

Assuming they even know what screens to show. EHR audit trails of user activity are notoriously imprecise.

(CNN) -- The Texas hospital treating the first person diagnosed with
Ebola on American soil says a "flaw" in its electronic health records
prevented doctors from seeing the patient's travel history. Patient
Thomas Eric Duncan told the nurse he'd been in Africa, but that
information was entered into a document that isn't automatically visible
to physicians, Texas Health Presbyterian Hospital Dallas said in a
statement Thursday.

However, the screens and the audit trail are the only way to authenticate the EPIC claims.

Wednesday, October 15, 2014

News and opinions about Ebola virus are swirling around the US, fueled by a tragic epidemic in West Africa, and fears that more infections could appear here. On October 6, 2014, I posted my concerns that despite a tremendous amount of confidence expressed by government officials and health care leaders, our dysfunctional health care system might have trouble containing Ebola virus. Less than two weeks later, my concerns do not seem so extreme. The first patient to be diagnosed with Ebola virus in the US has died. Two nurses who cared for him now have the virus.

There seem to be millions of words on paper and on the internet about Ebola appearing every day. So I certainly do not want to try to deal with the problem in all its aspects. I do want to revisit a particular set of issues from my October 6 post: the hazards posed by generic management deluded by business school dogma running health care institutions in the time of Ebola. In particular, my focus is the management of the US hospital at which one patient died, and two nurses were infected, based on what has come out since October 6.

The Incoherence of Hospital Leaders

On October 6, we noted that the hospital, Texas Health Presbyterian, part of the Texas Health Resources hospital system, had issued conflicting and confusing statements about why the first Ebola patient, Mr Thomas Eric Duncan, was sent home from the hospital when he first presented. The first specific statement by hospital managers was that there had been a problem with the hospital's electronic health record (EHR), as had been suspected by my fellow Health Care Renewal blogger, InformaticsMD. Then the hospital retracted that statement, but provided no explanation with which to replace it.

Since then, there have been more inconsistencies in statements made by hospital managers.

Fever or No Fever?

First hospital managers said Mr Duncan arrived without a fever, but then review of his medical records indicated his temperature was as high as 103 degrees F while he was in the hospital, a fever high enough that it might reasonably have prompted admission given his other symptoms, even if Ebola was not a concern. (See this Dallas Morning News story.)

The staff at Texas Health
Presbyterian Hospital of Dallas did a run-through just last week of
procedures to follow if the deadly virus landed in Dallas.

'We
were prepared,' Dr. Edward Goodman, an epidemiologist at Texas Health
Presbyterian, said Tuesday in a news conference. 'We have had a plan in
place for some time now in the event of a patient presenting with
possible Ebola. We are well-prepared to deal with this crisis.'

Presbyterian
said it is following recommendations from the U.S. Centers for Disease
Control and Prevention and the Texas Department of Health in responding
to the patient, described as being 'critically ill' at the hospital in
northeast Dallas.

All precautions are being taken to protect doctors, nurses and others in the hospital, officials said.

Sadly, this statement soon seemed, as one politician once said, inoperative. an October 14 Washington Post article described how hospital health professionals had to essentially make up their procedures as they went along.

The hospital that treated Ebola victim Thomas Eric Duncan had to learn on the fly how to control the deadly virus, adding new layers of protective gear
for workers in what became a losing battle to keep the contagion from
spreading, a top official with the Centers for Disease Control and
Prevention said Tuesday.

'They kept adding more protective
equipment as the patient [Duncan] deteriorated. They had masks first,
then face shields, then the positive-pressure respirator. They added a
second pair of gloves,' said Pierre Rollin, a CDC epidemiologist.

Also,

He said the hospital originally had no full-body biohazard suits
equipped with respirators but now has about a dozen. Protocols evolved
at the hospital while Duncan was being treated, he said: 'Collecting
samples, with needles, then you have to have two people, one to watch. I
think when the patient arrived they didn’t have someone to watch.'

Worse, in the last 24 hours, there have been reports by anonymous people said to be nurses at Texas Health Presbyterian that the hospital was clearly not ready, per the Los Angeles Times,

The nurses' statement alleged that when Duncan was brought to Texas
Health Presbyterian by ambulance with Ebola-like symptoms, he was 'left
for several hours, not in isolation, in an area' where up to seven other
patients were. 'Subsequently, a nurse supervisor arrived and demanded
that he be moved to an isolation unit, yet faced stiff resistance from
other hospital authorities,' they alleged.

Duncan's lab samples were sent through the usual hospital tube system 'without being specifically sealed and hand-delivered. The result is
that the entire tube system … was potentially contaminated,' they said.

The
statement described a hospital with no clear rules on how to handle
Ebola patients, despite months of alerts from the U.S. Centers for
Disease Control and Prevention in Atlanta about the possibility of Ebola
coming to the United States.

'There was no advanced preparedness
on what to do with the patient. There was no protocol. There was no
system. The nurses were asked to call the infectious disease department'
if they had questions, but that department didn't have answers either,
the statement said. So nurses were essentially left to figure things out
on their own as they dealt with 'copious amounts' of highly contagious
bodily fluids from the dying Duncan while they wore gloves with no wrist
tape, flimsy gowns that did not cover their necks, and no surgical
booties, the statement alleged.

In response, the official hospital statement (authored by one Wendell Watson, "a Presbyterian spokesman," according to the AP) contained vague assurances, but no specific responses to the allegations,

'Patient and employee safety is our greatest priority, and we take
compliance very seriously,' the hospital said in a statement. 'We have
numerous measures in place to provide a safe working environment,
including mandatory annual training and a 24-7 hotline and other
mechanisms that allow for anonymous reporting. Our nursing staff is
committed to providing quality, compassionate care, as we have always
known, and as the world has seen firsthand in recent days. We will
continue to review and respond to any concerns raised by our nurses and
all employees.'

So while hospital officials (and local and national politicians and government leaders) kept up reassuring statements that our sophisticated, high-technology hospitals were totally ready to deal with a disease like Ebola, the reality appeared far different.

Other Inconsistencies

According to a USA Today story, other inconsistencies included hospital statements about the date Mr Duncan's diagnosis was confirmed, and whether or not the hospital was diverting ambulances.

Were Health Professionals Silenced?

Of course, given the suddenness of the arrival of Ebola in the US, the acuity of the first patient, and the general atmosphere of panic, initial confusion in public statements however critical the information they were meant to contain may be, is understandable.

However, there are now allegations that hospital management was not merely confused, but trying to keep critical information secret, and the allegations do not seem incredible.

In a Washington Post story on October 12, about how many US hospitals seem not well prepared for Ebola infected patients, appeared this from Bonnie Castillo, director of Registered Nurse Response Network, part of the union, National Nurses United,

Castillo said the union has been trying to contact nurses at Texas
Health Presbyterian Hospital, where Thomas Eric Duncan, the Liberian man
diagnosed with Ebola, died Wednesday.

'That hospital has issued a
directive to all hospital staff not to speak to press,' Castillo said. 'That is a grave concern because we need to hear from those front-line
workers. We need to hear what happened there. … They have them on real
lockdown. There is great fear. This hospital is not represented by a
union. Our sense is they are afraid to speak out.'

The Dallas nurses asked the union to read their statement so they could
air complaints anonymously and without fear of losing their jobs,
National Nurses United Executive Director RoseAnn DeMoro said from
Oakland.

the labor organization National Nurses United read a statement that it
said came from nurses at the hospital who 'strongly feel unsupported,
unprepared, lied to and deserted to handle their own situation.'

The Presbyterian
nurses are not represented by Nurses United or any other union. DeMoro
and Burger said the nurses claimed they had been warned by the hospital
not to speak to reporters or they would be fired.

The
AP has attempted since last week to contact dozens of individuals
involved in Duncan's care. Those who responded to reporters' inquiries
have so far been unwilling to speak.

Covering up information vitally needed by health care professionals, other institutions, the government, etc to better manage a potentially fatal disease that is already epidemic in other countries appears completely unethical. Doing so to preserve the reputation of managers seems reprehensible. But the implication of the recent stories is that is what happened.

Why Hospital Managers May Not Deserve Our Trust

The US has had no recent experience with any disease like Ebola. So that mistakes, sometimes very serious ones, were made in the management of the first Ebola patients is not a big surprise.

What may be a big surprise to many Americans is how untrustworthy health care leaders, and in particular the managers of Health Texas Presbyterian hospital and its parent system, Health Texas Resources now appear. After all, USA Today published on October 14, "Texas Health Presbyterian was a respected, renowned hospital." While even people at respected, renowned institutions make mistakes when confronted with sudden, unfamiliar problems, should not the institution's leaders at least be trusted to in their public pronouncements?

Instead, it appears that the leaders appeared tremendously overconfident, and worse, may have silenced employees from raising concerns that could have reflected badly on leadership. This occurred in a context in which transparency was imperative so that other people who might have to deal with Ebola patients might be better prepared.

On the other hand, based on what we have been posting on Health Care Renewal for nearly 10 years, the conduct of the Texas Health Resources leaders should have come as no surprise. On Health Care Renewal we
have been connecting the dots among severe problems with cost, quality
and access on one hand, and huge problems with concentration and abuse
of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty.

We have seen many examples of hospital executives who seemed vastly impressed by their own brilliance, egged on by board members who were themselves executives of other organizations, and by marketing and public relations functionaries dependent on these executives for their own career advancement. In particular, we have posted examples of hospital CEOs and other top executives making millions of dollars a year based on their supposed "brilliance," or "visionary" capacity, at least according to the board members who supposed to be exercising stewardship over their institutions, and the public relations people they hired. Such brilliance has often been asserted, but rarely been explained or justified (The latest example was here, and much more discussion is here.)

Most such ostensibly "brilliant" hospital executives had no direct experience in clinical care, public health, or biomedical science.

Making hospital leaders feel entitled to make more and more money regardless
of their or their institutions' performance seems to be a recipe for "CEO Disease," leading to disconnected, unaccountable, self-interested leaders. Hospital leaders suffering from the CEO disease may be particularly willing to countenance suppression of any facts or ideas that might raise doubts about their brilliance.

So the leadership of Texas Health Resources may in fact be very typical of that of large non-profit hospital systems. THR is such a system. A Dallas Morning News article about Mr Doug Hawthorne, the Texas Health Resources CEO who just retired in September, 2014, stated

In 1997, Doug Hawthorne helped reshape the health care industry in North
Texas by leading the creation of Texas Health Resources, an alliance of
Presbyterian Healthcare Resources, Harris Methodist Health System and
Arlington Memorial Hospital.

By 2014,

With more than 22,000 employees in fully owned and joint venture
operations, Texas Health is one of the largest care providers in North
Texas. For its 2012 fiscal year, it had $3.7 billion in total operating
revenue and $5.3 billion in total assets.

For leading this system, Mr Hawthorne made a lot of money, although apparently no recent data is available on his compensation,

He was among the most highly compensated not-for-profit CEOs in the
region. For 2012, the most recent information available, his base salary
was about $1 million and his bonus was about $1.1 million.

'A healthcare visionary, Mr. Hawthorne is at the helm of one of the
largest faith-based, nonprofit health care delivery systems in the
United States, Texas Health Resources,' the Hall said in a release
announcing the induction.

Yet Mr Hawthorne had no direct patient care experience, public health experience, or biomedical or clinical science experience. Mr Hawthorne is on the board of directors of the LHP Hospital Group Inc, a for-profit that provides capital and services to non-profit hospitals. The official bio, posted by LHP stated his educational background only included

B.S. and M.S. degrees in healthcare administration from Trinity University in San Antonio.

Furthermore, as we mentioned earlier, the current CEO of Texas Health Resources, Mr Barclay E Berden, who has only been on the job since September 1, 2014, also was hailed by system board of trustees for his "unique leadership strengths." His current compensation is unknown, but I would guess is likely over $1 million/year. He highest degree is a MBA, and like his predecessor, had much experience in hospital management, but apparently none in clinical care, public health, or biomedical science.

Summary

Texas Health Resources' recent CEOs have been paid millions, and hailed for their brilliance, despite a lack of any direct experience in health care, public health, or biomedical science. Leaders convinced of their own brilliance may live in bubbles that prevent penetration of any ideas or facts that may challenge that brilliance, making them thus susceptible to hubris.

So should we have been surprised that the leadership of the first US hospital system to directly confront Ebola de novo seemed more concerned with polishing their supposed brilliance than with transparently providing the information that other people who have to confront Ebola in the future so greatly need?

No, but one tiny silver lining to the time of Ebola is that it may make it glaringly obvious that we need true health care reform that focuses on reforming the leadership of big health care organizations. In particular, we need leadership that is well-informed about health care and public health; that upholds the values of health care professionals, specifically by putting patients' and the public's health ahead of their own remuneration; is willing to be held accountable; and is honest and unconflicted.

Allowing the current dysfunction to continue, while it will be very profitable to the insiders who run the system, will continue to enable tragic outcomes for patients and the public.

... The first recorded epidemic ravaged the Byzantine Empire during the sixth century, and was named the Plague of Justinian after emperor Justinian I, who was infected but survived through extensive treatment.The epidemic is estimated to have killed approximately 50 million people in the Roman Empire alone.

Of course, epidemiology was not understood then - or even the nature of infectious disease.

... Bubonic plague is an infection of the lymphatic system, usually resulting from the bite of an infected flea, Xenopsylla cheopis (the rat flea). In very rare circumstances, as in the septicemic plague, the disease can be transmitted by direct contact with infected tissue or exposure to the cough of another human.

We supposedly understand infectious disease better now. We supposedly understand how to limit epidemics through quarantine of those affected, and via keeping those affected away from those who are not - via, for example, travel restrictions regarding entry into an unaffected country.

The second health care worker who tested positive for the Ebola virus [after caring for the late Thomas Duncan] took an airline flight from Cleveland to the Dallas/Fort Worth International Airport the day before she reported symptoms of the disease, federal health officials said Wednesday.

Why was this person on a commercial flight while supposedly being "monitored" for the disease? How did the worker get from Dallas to Cleveland in the first place? (Another flight, most likely.)

The federal Centers for Disease Control and Prevention said in a statement that “because of the proximity in time between the evening flight and first report of illness the following morning,” it was reaching out to passengers.

Frontier Airlines said Flight 1143 landed in Dallas-Fort Worth at 8:16 p.m. Monday and remained at the airport over night.

When, exactly, is the disease transmissible and when is it not? Before symptoms, "in proximity" to symptoms, after symptoms? The calls for "reaching out" suggests nobody is quite confident of the exact time of infectivity of an affected person.

The hospital worker, who has not been identified, was part of the medical team that cared for the Thomas Eric Duncan, the Ebola patient who was admitted to a hospital in Dallas on Sept. 28 and put in isolation. The worker reported a fever on Tuesday and was immediately isolated at Presbyterian hospital.

Crew members said the woman had shown no signs of illness while on the flight, according to a statement from the airline and the disease centers.

I don't think the crew members were either qualified or equipped to render a definite diagnosis.

The agency asked that all 132 passengers who took the Cleveland flight to contact the federal health authorities (1-800-232-4636). “Individuals who are determined to be at any potential risk will be actively monitored,” it said in a statement.

Why are all flight passengers being asked to contact the authorities, one wonders? Just who is "at potential risk?" What about people the worker may have contacted in the airport, in the waiting lines, in the restaurants, in the bathrooms?

Frontier said in a statement that the aircraft “received a thorough cleaning per our normal procedures,” at Dallas-Fort Worth and that it was then cleaned last night in Cleveland.

Is this some type of guarantee of non-spread of Ebola? I seem to recall the apartment of the first healthcare worker to contract the disease was fumigated.

It seems clear the mode of spread of this disease is not truly
understood to a great degree of confidence by our officials or governmental leaders.

What Ebola does apparently have, however, is up to a 70% mortality rate, and that rate is likely higher in children and the aged.

Our politicians, however, seem to have no problem with using the public
as laboratory specimens to figure out how the virus spreads, rather than taking
immediate action to, as in any epidemic, quarantine the sources.

Has quarantine all of a sudden been determined to have no role in limiting the spread of infectious diseases for which there is no treatment, and which have an exceptionally high mortality rate?

Is political correctness more important than our lives? What kind of idiots do we have as our leaders?

Why the hell was this healthcare worker - or any other worker potentially exposed to the virus - permitted to fly before the transmission of the virus is truly understood?Is not extreme caution with a disease of this nature, and scientific study in confined laboratory environments a wise path, rather than hope, wishful thinking, and putting the public health at risk?

Quarantine by travel restrictions is overdue, and it is unclear how many people will pay the price for that fundamental (and seemingly deliberate) scientific faux pas.

Welcome to the public's new role as laboratory rats. I, for one, did not sign up.

Thursday, October 09, 2014

As discussion, if not outright panic, about Ebola infections increases in the US, it is still hard to figure out what heath care professionals and the health care system need to do to protect patients and the public in a very changed world.

One pressing question is how to identify people at risk of having the infection so as to best care for them, and to protect the public from further spread of the infection, without swamping the health care system, needlessly reducing civil liberties, or spreading further panic.

To better answer question, better understanding why the first patient who was diagnosed with and then died from Ebola in the US was initially not diagnosed might help. However, at this time, the whole thing seems mysterious. As a column published on October 7, 2014 in the Dallas Observer was entitled,

On this blog, InformaticsMD was the first to speculate that problems with the design and implementation of an electronic health record (EHR) might have enabled the discharge of this patient, after he presented to the emergency department with non-specific symptoms soon after returning from Liberia. The next day, an official statement from Texas Health Resources seemed to confirm that a "flaw" in the hospital's EHR prevented adequate communication of the patient's travel history between a nurse and a physician. However, one day later, as InformaticsMD discussed here, the hospital reversed itself, releasing another statement that there was no "flaw" in the EHR. That statement, however, did not explain either why the first statement came out, or anything more about the diagnostic failure.

So, as the Dallas Observer column stated,

The question of why Duncan was sent home initially instead of isolated
is still the most stubborn mystery in the saga of 'Ebola Comes to
Dallas.'

As columnist Jim Schultze explained, this question has implications for health care professionals and health care organizations who need to figure out how to best deal with the next patient who shows up who might or might not have Ebola.

If Duncan's dismissal from the emergency room on his first visit was a
bungle, then it's reasonable to assume that everybody knows about the
bungle by now and a similar goof is unlikely to happen again at any
decent hospital in America. But if the handling of Duncan grew out of
something more systemic, especially a business or management style or
policy, then it may be less reasonable to assume the next hospital will
be immune from the same issue.

In other words,

if the Eric Duncan mistake flowed from something more systemic, then we
absolutely need to know what it was and how it happened so that we can
look for the same problems everywhere else. If it was a non-medical
problem, I can almost guarantee you it will turn out to be an issue not
be unique to this hospital.

Mr Schultze is not the only one to point out the critical need to solve this mystery. He quoted

former Boston hospital CEO, Paul Levy, called on Texas Health to open
up: 'A failure by a hospital to be open about what went wrong in a major
medical case such as this," Levy said, "does a major disservice to everyone else in the health care industry.'

The Texas Health situation may be setting a dangerous precedent. This
is a major world health crisis for which providers worldwide are trying
to prepare. If truly the mistake Texas Health made in releasing Duncan
was its mistake alone, so be it.

But if there really was a design flaw, then every provider--and every
vendor--needs to know about it, evaluate whether it has the same
problem, and correct it.

The patients deserve no less.

So far, to date, we have heard nothing more from the managers of Texas Health Presbyterian or its parent non-profit corporation, Texas Health Resources. It appears we need a reincarnation of Sherlock Holmes to solve this one.

Sifting a Few Clues

I am not he. But I do believe there are some clues, however, weak, that suggest system flaws. They can be found in an interview of the new Texas Health Resources chief operating officer (COO), Dr Jeffrey Canose, published in Healthcare Informatics a few weeks before Mr Duncan presented first to the Texas Health Presbyterian emergency department.

One of his points was that the hospital system is changing its emphasis from acute care to population health (however that may be defined),

we made the decision to become more of an integrated health system, and
started to build the infrastructure for population health

Then,

The biggest challenge is to continue on our journey to increase our
capabilities as a fully integrated health system; to develop the
competency to be a high-performing system in the realm of population
health management; to shift our focus from sick care to actually
managing well-being....

Also, he referred to participation in the Pioneer ACO program as

one of our first significant efforts in shifting our focus from being
acute-care-centric to being more focused on the full continuum of care

Recall Mr Schulze's point that the failure to diagnose Mr Duncan could have been due to a business management style or policy. So maybe we have a clue that the hospital's policy to reduce emphasis on acute care, including the emergency department, might have had to do with problems in the ED leading to a diagnostic misadventure.

In addition, Dr Canose noted,

the electronic health record is a huge enabler to all this; the next
challenge will be to enable things further, including through data
mining, working with big data, and clinical and operational support

So,

around collaboration at the sharp point of redesigning patient
care—... people in IT are mission-critical partners in hearing what
kinds of problems we’re trying to solve, and in helping us to figure out
how to drive clinical transformation and care design, and how to drive
efficiency.

So maybe we have a clue that the management was very heavily intellectually invested in their health care information technology infrastructure, and perhaps thus less willing to think about how health care IT could be the cause, rather than solution of problems, such as diagnostic problems in the ED.

Finally, this may be just a hint, but Dr Canose spoke

We have a clear focus on continuing to elaborate the infrastructure we
need in order to do population health management, and we’re continuing
to build those capabilities over time, and explore ways we can deploy
through our employed physician groups,...

This implies that many physicians who practice at Texas Health Resources hospitals are in fact its employees. We have at times written about the perils being a corporate physician. One is loss of autonomy, as physician employees become beholden to organizational managers. So maybe we have a clue that physicians' loss of autonomy, perhaps the autonomy to put patients ahead of corporate policies and managerial edicts, such as those deemphasizing emergency care, could have enabled the failure to diagnose the Ebola "patient zero?"

Summary

We wrote earlier that the rise of generic managers as leaders of health care organizations degrade the US' ability to deal with Ebola. In the mystery of the discharged Ebola patient, we seem to see the sort of managerial obfuscation that seems characteristic of many generic managers. More transparency from the management of Texas Health Resources would surely help the US deal better with the ongoing challenge of Ebola. In the long run, Ebola may teach us a hard lesson about the need to put health care leadership in the hands of people who understand health care, and subscribe to its mission to put patients and the public health first.

Tuesday, October 07, 2014

In the past several days the media has been abuzz with stories about the admission, then the following retraction, by a Texas hospital that and EMR "flaw" had caused a man who had been in West Africa and was infected with the Ebola virus to be sent home, instead of admitted and put into isolation.

Some people such as myself with specific Medical Informatics experience and who know the failure modes via AHRQ, FDA, ECRI Institute etc. believe the EHR was quite likely contributory or causative of the mistake (see my April 9, 2014 post "FDA on health IT
risk: "We don't know
the magnitude of the risk, and what we do know is the tip of the
iceberg, but health IT is of 'sufficiently low risk' that we don't need
to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

The reason I have written little after my initial two posts is that the only was to resolve the controversy is to actually examine the EHR screens, screen navigation and behavior of the EHR, if possible both before and after the hospital's stated "fix" of the problem, the EHR audit trails (automatically generated EHR accounting logs of user accesses, action taken, time, location etc.) and to examine the EHR in actual operation to evaluate it in context with the clinical setting in which it was installed.

Barring that, everything else is speculation usually biased either by the speculator's own beliefs about either the beneficence or fallibility of information technology in healthcare, and perhaps IT generally, and/or conflicts of interest.

Unfortunately, considering the health IT industry and environment, the only way I believe such an examination of the EHR can come about is via litigation. I doubt it will come from the traditional regulators of medical devices and healthcare safety.

I do note the following of interest at Politico:

... While all EHRs difficult to use, some are set up better than others.

At Mount Sinai Hospital in New York City, information that a patient
was feverish and recently flew in from Liberia would have set off an
alarm, with the nurse’s screen flashing yellow and giving instructions
to immediately isolate the patient, said Jason Shapiro, an emergency
room physician and informatics expert at the hospital.

The nurse entering “fever” into the record would “get a hard stop.
They immediately have to enter a response to a travel history question.
And if there’s fever and the right kind of travel history, the whole
isolation mechanism is supposed to swing into play,” Shapiro said.

... Both Mount Sinai and Texas Health Presbyterian have health records
systems they purchased for hundreds of millions of dollars from Epic.

At least some users of EPIC seem to have a system configured to catch such a problem. In my mind, this speaks the need to industry regulation, to ensure all EHRs meet basic standards of safety and reliability and are not haphazardly designed or implemented from one hospital to the next.

-- SS

10/9/14 Addendum:

Prof. Jon Patrick of Australia, cited numerous times on this blog, relates this:

"I always talk about data capture and data reuse and the reuse is defined
by the data flows required in the design of the system. EPIC might well
have allowed for the the data capture but failed to deal with the data
flow to properly effect the required reuse."

As may the implementers at the hospital in question also have failed at the flows supporting appropriate and fail-safe reuse in a hectic ED environment.

He adds, for further clarification:

A footnote to this point. We separate data flow from work flow. Data flow is the movement of data from context to reuse in another
context, or you collect data on this screen(first context) and then you
see it later on another screen (=another context).

Workflow is
the route staff team members take in moving from one context to
another, that is the movement from using one screen to another screen.
Most often triggered by clicking a button that moves you to the chosen
screen(next context).

The two are very different things and
require close thinking in both cases to not trip up with unhelpful
and frustrating system solutions.

Historically, Information
Systems development has dealt with these issues both poorly and without
adequate separate planning. In the past the focus has been on the data
capture and storage, because the notion of reuse and context shifting
has been left behind. This has been OK for many business systems where
contexts have only small variations and workflow are simple or
unimportant.

There is no country in the world better prepared than the United States to deal with this. We have the best public health infrastructure and the best doctors in the world.

However, at least the statistics say compared to other developed countries, US processes and outcomes are at best
mediocre using the best of some admittedly flawed metrics (look here), yet our costs are much higher than those of comparable countries. Furthermore, on Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty.

Thus there is reason to worry that it will be harder than many expect for the US to deal with Ebola. There is already some evidence that some of the sorts of problems we have been discussing for years made it harder for the US to cope with even the so far limited incursion of Ebola.

We try never to forget that medicine is for the people. It is not for
the profits. The profits follow, and if we have remembered that, they
have never failed to appear. The better we have remembered it, the
larger they have been.

In the pharmaceutical industry, the era of George W Merck is over. The failure to have access to an effective Ebola virus vaccine exemplifies how things have changed.

If we were to have an effective Ebola virus vaccine, we could have likely used it to vaccinate health care workers and contacts of infected patients and likely thus halt the epidemic early.

A story in Modern Healthcare
suggested that now many of the big experts on Ebola and public health
are concluding having a vaccine available would be very helpful,

As West Africa's Ebola outbreak continues to rage, some experts are coming to the conclusion
that it may take large amounts of vaccines and maybe even drugs — all
still experimental and in short supply — to bring the outbreak under
control.

Specifically,

'It is conceivable that this epidemic will not turn around even if we
pour resources into it. It may just keep going and going and it might
require a vaccine,' Dr. Anthony Fauci, director of the U.S. National
Institute for Allergy and Infectious Diseases, told The Canadian Press
in an interview.

The main reason we do not yet have such a vaccine does not appear to be scientific, but economic.

Here we posted discussion of arguments that pharmaceutical and biotechnology companies up to now have been uninterested in developing Ebola vaccines because they did not anticipate that such vaccines would produce a lot of revenue. About one month ago, the Independent ran yet another story about an Ebola expert who believed this was the main reason for the lack of effective vaccine development up to now.

The scientist leading Britain's response to the Ebola pandemic has
launched a devastating attack on 'Big Pharma', accusing drugs giants
including GlaxoSmithKline (GSK), Sanofi, Merck and Pfizer of failing to
manufacture a vaccine, not because it was impossible, but because there
was 'no business case'.

West Africa's Ebola outbreak, which has now claimed well over 2,000
lives, could have been 'nipped in the bud', if a vaccine had been
developed and stockpiled sooner – a feat that would likely have been 'do-able', said Professor Adrian Hill of Oxford University.

The US health care system is now heavily commercialized. Health care
corporations, including pharmaceutical and biotechnology companies, are
often lead by generic managers who subscribe to the business school dogma of the
"shareholder value theory," which seems to translate into putting
short-term revenues ahead of all other goals. Thus they have been "financialized." At least in the pharmaceutical and biotechnology sector, such financialization appears to now be global.

It may now be too late to contain this particular Ebola virus epidemic using a vaccine. But unless we change how decisions are made about vaccine development, and end the dominance of financialization over drug and vaccine development, we may not be able to control the next deadly epidemic using vaccines either.

Generic Management Deluded by Business School Dogma

On 2 October, 2014, InformaticsMD posted on Health Care Renewal his speculation that the Ebola patient now hospitalized in Dallas was not identified on his first emergency department visit to Texas Health Presbyterian hospital even though a nurse apparently found out he had recently traveled from Liberia because of problems with how the hospital's electronic health record (EHR) transmitted or displayed this information. This supposition was later apparently confirmed, but then the hospital system CEO retracted this explanation, leaving the reason he was sent home from the ED, thus risking infection of more contacts, unclear (see this post).

I now speculate that the larger reason for the problems the hospital had and is having both handling this patient, and explaining how it handled the patient is hospital leadership by generic managers who do not really understand the relevant health care issues.

Mr Barclay E Berden, the CEO of Texas Health Resources, has had a long career in hospital management. However, his most advanced degree was "a master's degree in business
administration with a specialization in hospital administration from the
University of Chicago Graduate School of Business." His official biography suggests that he has no direct experience or training in medicine, health care, or biological sciences. Nonetheless, when he became CEO this year, according to Modern HealthCare, the chairperson of the hospital system board thought he was fully qualified,

'He brings a well-rounded perspective and unique leadership strengths to
the CEO position,' board Chair Anne Bass said in a news release. 'At
the same time, he represents stability and continuity that will be
critical to advancing our strategy as we confront the challenges of a
rapidly changing healthcare environment.'

Nonetheless, the hospital systems seems to have had trouble confronting the challenges of the change in environment due to Ebola. Also, according to a very recent story in the Dallas Morning News, there have been performance issues at Texas Health Resource hospitals, and specifically at Texas Health Presbyterian,

Texas Health Presbyterian Hospital — under fire for releasing a
Liberian man who later turned out to have the Ebola virus — has lagged
behind its peers on emergency room care and lost some federal funds the
past three years because it had high discharge rates of patients who
later had to return for treatment.

The hospital scored
significantly worse than the state and national averages in five of six
emergency care indicators, with emergency room wait times twice as long
as the averages, according to data from the U.S. Centers for Medicare
& Medicaid Services.

The hospital also was the most penalized
in Dallas under a three-year program designed to reduce the number of
patients readmitted for care, according to the data.

The delays in
patient treatment in the emergency room, in particular, raise important
questions about Presbyterian’s emergency care, said Dr. Ashish Jha, a
professor at Harvard University’s School of Public Health and a
practicing general internist.

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance,
a book published in the Netherlands, that to decrease health care costs
it would be necessary to break up the "physicians' guild" and replace
leadership by clinicians with leadership by managers (see 2006 post here).
Thus from 1983 to 2000, the number of managers working in the US health
care system grew 726%, while the number of physicians grew 39%, so the
manager/physician ratio went from roughly one to six to one to one (see
2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician.

We have frequently discussed how generic managers in charge of health care organizations may follow business-school dogma at the expense of patients' and the public's health. In particular, they may also prioritize short-term revenue ahead of all other concerns, and hence may favor high-technology and procedural care, often performed electively, ahead of the the less glamorous and remunerative parts of health care, e.g., ED care of poor, uninsured, febrile patients.

Unfortunately, much of the country's efforts to ward off Ebola are likely to be lead by generic managers who may have little understanding of epidemiology, public health or virology, and little understanding of the state of health care at the sharp end. So unfortunately I expect continuing "glitches," or worse. Hopefully, the country, although not every single one of its inhabitants, will survive them. Then we need to seriously reflect on the wisdom of handing control of health care over to generic managers, rather than health care professionals.

Commercialization of Health Care Leading to Neglect of Routine Acute Care and Public Health

Just as national politicians and government leaders have repeated the meme of the US health care system being "the best in the world," now that Ebola has come to Texas, state leaders have sung the same song. For example, an editorial in the Baltimore Sun quoted the state health commissioner,

'This is not West Africa,' Texas health commissioner Dr. David Lakey
said Wednesday at a news conference designed to dispel Texans' (and
Americans') fear of an Ebola outbreak after a man there was diagnosed
with the disease. 'This is a very sophisticated city, a very
sophisticated hospital.'

The Texas Tribune ran a story produced in cooperation with Kaiser Health saying,

At a Wednesday press conference to discuss the Ebola case, Gov. Rick Perry
said he was confident in the state’s preparedness. 'There are few
places in the world better equipped to meet the challenge that is posed
in this case,' he said. 'We have the health care professionals and the
institutions that are second to none.'

However, another Dallas Morning News story recounted various problems in the public health response to the Dallas Ebola patient, including,

Delay in blood testing
After
Duncan was admitted to the hospital, health officials waited nearly two
days to test his blood for the Ebola virus. This may have delayed
containment of people who had contact with him.Slow containment and cleanup
Health officials left some of Duncan’s close contacts in the apartment where soiled linens and towels that he had used remained.Failure to avoid contact with emergency workers
Ambulance workers and sheriff’s deputies are among those being monitored.

So, there is reason to suspect that the public health system in Texas may not exactly be the best in the world. In fact, there seem to be systemic problems with public health in Texas that the Ebola scare is bringing to increased public notice. The Texas Tribune/ Kaiser story went on to explain that in Texas, a state in which distrust of central government is great, and confidence in the private sector is high, public health is both decentralized and often poorly funded,

'We don’t really have a unifying construct for public health in Texas
that’s comprehensive,' said Dr. Eduardo Sanchez, the former commissioner
of the Texas Department of State Health Services (DSHS) and current
chairman of the Texas Public Health Coalition. 'The system is not as
connected as it could be.'

Furthermore,

But public health experts argue that the state’s response
system is 'fragmented' and vulnerable to local budget cuts, which they
say could hamper crisis-response efforts in the case of diseases that
are more easily transmitted.

Texas’ local health departments, which provide services
like immunizations and disaster response planning, operate autonomously
and are funded primarily by local taxes but may be supplemented by state
and federal grants. Because local health departments are not held to a
single standard, their services and budgets vary tremendously around the
state.

A report
critical of the state’s public health system, prepared by the Sunset
Advisory Commission, found that 'the roles and responsibilities of DSHS
and local health departments remain undefined.' The Sunset Commission is
tasked with highlighting inefficiencies at state agencies and
recommending legislative action.

'A ‘local health department’ can be a few staff conducting
restaurant inspections and animal control duties, or a large agency
directing sophisticated disease surveillance, operating a public health
laboratory and providing direct services to citizens,' according to the
report.>

Some public health officials have criticized the state’s
model as disjointed. Many local health departments operate
independently; however, if local budget cuts to a public health
department force it to discontinue a health service, DSHS is often
required to step in and take responsibility for that service. The state
is then left to foot the bill.

'In the event of a public health emergency ... the
resources necessary to adequately respond to that are not all in the
control of the health department,' Sanchez said. 'You have to have the
money and the authority — whether it’s informal or formal — to actually
lead a response and take care of business.'

Local entities have slashed funding for health departments
in recent years, said Catherine Troisi, an epidemiologist at the
University of Texas School of Public Health in Houston. Thirty-six
percent of local health departments in Texas laid off staff as a result
of budget cuts between 2008 and 2013, according to the National
Association of County and City Health Officials.

'Public health is politics,' Troisi said.

In the US, we have pushed commercialization of health, health care and public health. Much of our health insurance is provided by for-profit corporations. Some of our hospitals and other organizations that provide direct patient care are for-profit. As we noted above, most of our health care organizations are now run in a "business-like" manner by managers trained in business, but not necessarily in health care or biological science. The thus revenue-focused health care system has emphasized procedures and high-technology, often at the expense of the basics. So it should not be s surprise that Reuters just reported,

Nurses, the
frontline care providers in U.S. hospitals, say they are untrained and
unprepared to handle patients arriving in their hospital emergency
departments infected with Ebola.

Many
say they have gone to hospital managers, seeking training on how to
best care for patients and protect themselves and their families from
contracting the deadly disease, which has so far killed at least 3,338
people in the deadliest outbreak on record.

Furthermore, using as an example Medstar Washington Hospital Center, the largest hospital in Washington, DC,

Nurses argue that inadequate
preparation could increase the chances of spreading Ebola if hospital
staff fail to recognize a patient coming through their doors, or if
personnel are not informed about how to properly protect themselves.

At Medstar, the issue of Ebola training came up at the bargaining table during contract negotiations.

'A
lot of staff feel they aren't adequately trained,' said [Emergency Department nurse Micker] Samios, whose
job is to greet patients in the emergency department and do an initial
assessment of their condition.

So Young Pak, a spokeswoman for
the hospital, said it has been rolling out training since July 'in the
Emergency Department and elsewhere, and communicating regularly with
physicians, nurses and others throughout the hospital.'

Samios
said she and other members of the emergency department staff were
trained just last week on procedures to care for and recognize an Ebola
patient, but not everyone was present for the training, and none of the
other nursing or support staff were trained.

'When
an Ebola patient is admitted or goes to the intensive care unit, those
nurses, those tech service associates are not trained,' she said. 'The
X-ray tech who comes into the room to do the portable chest X-ray is not
trained. The transporter who pushes the stretcher is not trained.'

If an Ebola patient becomes sick while being transported, 'How do you clean the elevator?'

Nurses at hospitals across the country are asking similar questions.

A
survey by National Nurses United of some 400 nurses in more than 200
hospitals in 25 states found that more than half (60 percent) said their
hospital is not prepared to handle patients with Ebola, and more than
80 percent said their hospital has not communicated to them any policy
regarding potential admission of patients infected by Ebola.

Another 30 percent said their hospital has insufficient supplies of eye protection and fluid-resistant gowns.

So up to now, it appears that in the state of Texas, and across the country, the preparedness of public health systems and of front-line hospitals to deal with Ebola is unclear. This may be due to political cuts in funding of public agencies, a payment system that favors procedures and high-technology over basic care, and leadership by generic managers who prioritize making money short-term over less financially advantageous priorities like preparedness for epidemics.

Summary
Thus again there is reason to fear that our commercialized health care system run by generic managers, and our neglected public health system scorned because it is not "business-like" may not be fully up to the task of containing Ebola. Again, hopefully this too will pass, without too many casualties. However, one, maybe the only silver lining in the dark clouds of the Ebola crisis seem to be its capacity to challenge the pompous certainty by those invested in the status quo that we have the best health care system in the world.

The Ebola crisis should, again, lead to serious reflection on true health care reform, reform that would address concentration and abuse of power, reform that would enable leadership of health care by well-informed people who are devoted to patients' and the public's health, who are honest and ethical, who are willing to be held accountable, and would shrink the size and power of individual health care organizations to make them truly responsive to patients' health care needs and the public's health needs.

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